FDA 510(k) Application Details - K020808

Device Classification Name	Test, Luteinizing Hormone (Lh), Over The Counter   More FDA Info for this Device
510(K) Number	K020808
Device Name	Test, Luteinizing Hormone (Lh), Over The Counter
Applicant	PHEROMONE SCIENCES CORP. 443 KING ST. EAST 2ND FL TORONTO M5A 1L5 CA Other 510(k) Applications for this Company
Contact	JEFFREY T SOLATE Other 510(k) Applications for this Contact
Regulation Number	862.1485   More FDA Info for this Regulation Number
Classification Product Code	NGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2002
Decision Date	09/23/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review